Clinician's Digest - Page 4

Stronger Placebos

What are they putting into placebos, those supposedly inert pills with no medicinal effect that have long been the benchmark against which the effectiveness of new medications are measured? Something's going on, because placebos are getting stronger. An intriguing metanalysis in the November 2009 Journal of Affective Disorders, for example, found that the potency of placebos has nearly doubled between 1985 and 2005. How can that be?

The question has important ramifications. Because the Food and Drug Admin-istration (FDA) requires new medications to show significantly more effectiveness than placebos, fewer and fewer drugs have gained approval in recent years. Writing in the September 17 issue of Wired, journalist Steve Silberman points out that if they were to undergo clinical trials today, several widely used antidepressants wouldn't make it to market. In 2007, the FDA approved the fewest drugs since 1983, despite the record amount of money that pharmaceutical companies had spent on research and development. Half of late-stage trial failures of new drugs happened because they couldn't outperform placebos by a wide enough margin, says Silberman.

As brain-imaging technology has revealed that people's expectations produce actual brain reactions, the key to understanding placebos has shifted from the notion that their effect is purely imaginary to a new appreciation of their real physiological impact. Silberman speculates that the pharmaceutical companies may be victims of their own multimillion-dollar advertising successes. Press reports and mass advertising have led us to believe increasingly in the power of medications, so clinical trial subjects and raters (whose unconscious biases often influence results) may have developed higher expectations that pills will work.

Instead of arguing about how to reduce the incidence of placebo response, suggests Silberman, we ought to think about how to better use the placebo effect in treatment, something already done by many doctors who frequently prescribe pills and supplements they know are the equivalent of vitamins. Skeptics about the effectiveness of psychotherapy treatments suspect that many therapists, both consciously and unconsciously, are doing something similar. In the meantime, discussions are already going on about whether the FDA needs to rethink its guidelines on clinical efficacy, as well as how researchers can better differentiate between the effects of placebo and active treatments. As the links between mind and body become harder to disentangle, the previously held distinctions between medication, placebo, and a plethora of other therapies may soon seem less important than the notion that whatever works, works.

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